Theralase Files ITA Application to Health Canada
Toronto, Ontario – July 29, 2016, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that it has filed an Investigational Testing Authorization (“ITA”) with Health Canada for approval to use its patent pending TLC-3200 Photo Dynamic Therapy (“PDT”) Laser System and TLC-34XX Dosimetry Fibre Optic Cage (“DFOC”) technology, in conjunction with its Clinical Trial Application (“CTA”) approved lead PDC, TLD-1433, in a Phase Ib clinical trial for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”).
The TLC-3200 PDT Laser System delivers green laser light, at a wavelength of 525 nanometers (“nm”), while the DFOC technology precisely monitors the laser light to provide a uniform distribution of the laser light energy, in the correct dosage, to the bladder wall.
The clinical procedure for the Phase Ib study to treat NMIBC, titled “A Phase Ib Trial of Intravesical Photodynamic Therapy in Patients with Non-Muscle Invasive Bladder Cancer at High Risk of Progression Who are Refractory to Therapy with Bacillus Calmette-Guerin (“BCG”) and Who are Medically Unfit For or Refuse a Cystectomy” is to:
- Intravesically instill a sterile water based solution of TLD-1433 via catheter, through the urethra, into the bladder of a patient inflicted with NMIBC, who has failed standard of care and who is not indicated or refuses to have their bladder removed
- Allow the solution of TLD-1433 to absorb into any resident bladder cancer tumours for approximately sixty minutes
- Void the bladder and flush the bladder twice with sterile water to remove any excess TLD-1433 solution not absorbed by any bladder tumours
- Admit the patient into the operating room and administer a general anesthetic
- Insert a rigid cystoscope through the urethra of the patient into the bladder
- Fill the bladder with sterile water to provide shape to the bladder
- Insert the TLC-34XX DFOC device into the bladder via the cystoscope’s working channel and connect it to the TLC-3200 PDT Laser System
- Deploy the DFOC in the bladder (like an umbrella) to strategically place optical detectors at twelve (12) predetermined locations along the bladder wall to precisely monitor the laser light to provide a uniform distribution of the laser light energy, in the correct dosage, to the bladder wall
Pending Health Canada approval of the ITA, Theralase will immediately commence enrollment of patients into a Phase Ib clinical study in the treatment of NMIBC. The primary outcome measures of the Phase Ib clinical study will be safety and tolerability, with a secondary outcome measure of pharmacokinetics (where the drug accumulates in tissue and how it exits the body) and an exploratory outcome measure of efficacy.
Roger Dumoulin-White, President and CEO of Theralase stated that, “The Company and its team of dedicated professionals have worked tirelessly over the last 7 months to design, optimize, test and
manufacture the hardware and software of the TLC-3200 PDT Laser System and the TLC-34XX DFOC technology and to compile the data for a Health Canada ITA application, providing support for claims of: biocompatibility, sterility, electrical safety, functionality and mechanical integrity of the technology. We look forward to a favourable and timely review by Health Canada to allow us the ability to commence the Phase Ib clinical study for NMIBC.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes patented super-pulsed
laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy (“PDT”) Division researches and develops specially designed molecules called Photo
Dynamic Compounds (“PDCs”), which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
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